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Eur J Cardiothorac Surg 2000;17:455-461
© 2000 Elsevier Science NL

Twenty years experience with pediatric pacing: epicardial and transvenous stimulation

^a Department of Thoracic and Cardiovascular Surgery, University Hospital, Pauwelsstraße 30, 52057 Aachen, Germany
^b Department of Pediatric Cardiology, University Hospital, Pauwelsstraße 30, 52057 Aachen, Germany

Corresponding author. Tel.: +49-241-808-9957; fax: +49-241-888-8454
e-mail: sachwehjs{at}aol.com

	Abstract

Top Abstract 1. Introduction 2. Materials and methods 3. Results 4. Discussion Appendix A. Conference... References

 
Objective: Permanent cardiac pacing in children and adolescents is rare and often occurs by means of epicardial pacing. Based on two decades of experience, operative and postoperative data of patients with epicardial and transvenous pacing were analyzed retrospectively. Methods: Between October 1979 and December 1998, 71 patients (mean age, 5.3±4.2, range, 1 day–16.2 years; mean body weight, 18±12; range, 8–56 kg) underwent permanent pacemaker implantation. Indications were sinus node dysfunction and atrio-ventricular block following surgery for congenital heart disease (69%), or congenital atrioventricular block (31%). Pacing was purely atrial (1.4%), purely ventricular (73%), ventricular with atrial synchronization (5.6%), or atrioventricular synchronized (20%). Epicardial pacing was established in 49 (69%), transvenous in 22 (31%) patients. Follow-up was 3.4±3.8 years (epicardial) and 3.0±4.0 years (transvenous). Results: Epicardial leads were implanted in younger patients (mean age: 4.5 vs. 7.0 years, P<0.05) and preferably after surgery induced atrioventricular block (78 vs. 46%, P<0.05). The youngest patient with transvenous pacing was 1.3 years old (weight, 8.5 kg). At implantation epicardial ventricular stimulation threshold at 1.0 ms was 1.07±0.46 vs. 0.53±0.31 V (transvenous) (P<0.05). The age-adjusted rate of lead-related reoperations was significantly higher in patients with epicardial leads (P<0.05), mainly due to increasing chronic stimulation thresholds resulting in early battery depletion. In three patients who received steroid-eluting epicardial leads initial low thresholds persisted after five month to one years. In two patients with recurrent epicardial threshold increase, steroid-eluting epicardial leads led to good acute and chronic thresholds after nine to 15 month. Two post-operative death (2.8%) were probably due to a dysfunction of the (epicardial) pacing system. Conclusions: Transvenous pacing in the pediatric population is associated with a lower acute stimulation threshold and a lower rate of lead-related complications. If epicardial pacing is necessary (e.g. small body weight, special intracardiac anatomy (e.g. Fontan), impossible access to superior caval vein), steroid-eluting leads may be considered.

Key Words: Cardiac pacemaker • Heart surgery • Congenital heart disease

	1. Introduction

Top Abstract 1. Introduction 2. Materials and methods 3. Results 4. Discussion Appendix A. Conference... References

 
Only 1% of the population requiring permanent pacemaker implantation is younger than 21 years old [1]. Main indication for permanent pacing in childhood is atrioventricular block following open-heart surgery for congenital heart disease with a frequency of about 1% of operated cases [2]. The other most important indication is congenital atrioventricular block with an incidence of one out of 20 000 births [1,3]. Because of either cardiac anatomy or small size, permanent pacing in children often occurs by means of epicardial leads. These leads have a shorter longevity compared to endocardial leads, because of an increase in stimulation threshold by time [1,4–6]. Yet, advances in lead and pacemaker technology, especially the development of steroid-eluting epicardial leads, have offered new therapeutical and surgical opportunities. Against this background, the experience with epicardial and transvenous pacing based operative and postoperative data is reported.

	2. Materials and methods

Top Abstract 1. Introduction 2. Materials and methods 3. Results 4. Discussion Appendix A. Conference... References

 
2.1. Patient characteristics
Between October 1979 and December 1998, 71 patients, mean age 5.3±4.2 years (range, 1 day–16.2 years), mean body weight 18±12 kg (range: 1.8 to 56 kg) underwent permanent pacemaker implantation. Indications were symptomatic postoperative sinus node dysfunction and complete atrioventricular block in 49 patients (69%), or congenital atrioventricular block or sinus node dysfunction in 22 patients (31%).

Following cardiac surgery, pacemaker implantation was performed after persistend complete heart block of 9–12 days postoperatively and was verified by Holter ECG. This group of patients had undergone intracardiac surgery for atrioventricular septal defect (n=10), complex transposition of the great arteries (n=11), univentricular heart (n=6), tetralogy of Fallot (n=3), ventricular septal defect (n=2), ostium primum defect (n=2), subaortic stenosis (n=3), hypertrophic obstructive cardiomyopathy (n=2), and miscellaneous complex congenital heart disease (n=10).

Diagnosis of a non-surgical atrioventricular block was made at the mean age of 5.4 years and was established between intra-uterine life up to the age of 13.5 years. Considerable bradycardia either symptomatic or revealed by Holter-ECG led to permanent pacemaker implantation at the age of 5.4±4.2 years (range, 1 day–13.7 years). Additional cardiac malformations were congenitally corrected transposition of the great arteries in three patients.

These patients were retrospectively divided into two groups according to the epicardial 49/71 (69%) or transvenous 22/71 (31%) pacing site. History, operative notes, hospital charts and routine pacemaker check-up data at outpatient clinic were reviewed retrospectively to evaluate the operative and postoperative course. Special regard was given to acute and chronic pacing characteristics, and lead-related complications.

2.2. Pacing characteristics
The pacing mode was purely atrial (AAI) in one patient (1.4%), ventricular with atrial synchronization in four (VAT=1, VDD=3, 5.6%), ventricular without atrial synchronization (VVI) in 52 patients (73%), and atrioventricular in a synchronized mode (DDD) in 14 patients (20%). Through the 20 years time span a variety of pacemaker devices and leads (Table 1) were used, reflecting the technological progress during this interval.

In patients with transvenous stimulation Vitatron: Finesse 201P (6), Vita 130 (1); Pacesetter: Regency SR (7); Biotronik: Pikos 01 (1), Actros DR (1), Acsos SR (1); Medtronic: Kappa SR 401 (1), Kappa DR 40 (2), 8423 (1), and Minix 8341 (1) were used.

2.3. Surgical technique
Different techniques were used for epicardial pacing, reflecting the difficulty of this procedure. In 42/49 (86%) the leads were placed via subxyphoid approach or midline sternotomy and battery was stored in the fascia of the musculus rectus abdominis; in one patient (2%) the battery was placed at the lateral abdominal wall.

In five patients (10%) the atrial and ventricular lead were placed via sternotomy approach (n=1) or via left (n=1) or right (n=3) thoracotomy without opening the pleura. In these patients the batteries were placed in the lateral thoracic wall after partial resection of the 5th and 6th rib to achieve space for large atrioventricular synchronized pacemaker. In one patient (2%) the leads were placed via sternotomy and battery was intrapleural to the right thoracic wall.

Usually, the atrial lead was fixed close to the sinus node, the ventricular lead was fixed mostly to the diaphragmal site of the right ventricle since it is almost free from adhesions of former cardiac operations and best to access from a subxiphoid approach.

After dissection of the cephalic vein in the Mohrenheim's fossa the transvenous leads were inserted directly via the vein or if the vessel was to small in diameter or forward moving of the lead was impossible – via puncture of the subclavian vein. Subsequently, the pacemaker was placed in a subpectoral pocket (right=17, left=2) (90.5%) storing the redundant leads under the battery. In one patient the internal jugular vein and in another patient the external jugular vein was dissected in the right cervical triangle and the lead was inserted and placed in the right ventricle. These leads were guided through the subcutaneus tissue and were connected to the battery in the right lateral abdominal wall. An atrial lead loop for anticipated patient grow was performed in eight patients (36%). Active lead fixation was used in all atrial leads and in 19/20 (95%) ventricular leads.

2.4. Follow-up
Follow-up was conducted until June 1999 and was obtained in 66 patients (93%) for 3.2±4.0 years (range: 1 month–12.9 years). Seven patients (9.9%) were lost to follow-up and eight died (11%). There is no significant difference in individual follow-up time of both groups (3.4±3.8 vs. 3.0±4.0 years).

2.5. Statistical analysis
Statistical analysis was performed with the Statistical Package for Social Sciences (SPSS-Inc., Chigago, IL). Data were expressed, where appropriate, as mean±standard deviation and range. Differences among two groups were compared using the Chi-square, Fisher exact, and Mann–Whitney U–Wilcoxon rank sum tests. As age was significantly different in both groups, time-related events among groups were compared using the Cox regression adjusted for age. A significance level of less than 0.05 was considered significant.

	3. Results

Top Abstract 1. Introduction 2. Materials and methods 3. Results 4. Discussion Appendix A. Conference... References

 
3.1. Patient characteristics
Epicardial leads were placed in significantly younger and smaller patients and were significantly more often used after surgical damage to the conduction system than in case of congenital heart block (Table 2).

3.3. Acute ventricular stimulation threshold, sensing, and impedance
Acute ventricular stimulation threshold at 1.0 and 0.5 ms pulse width is significantly higher in patients with epicardial pacing site. Three patients with steroid-eluting epicardial leads show a lower ventricular stimulation threshold (Fig. 1). Comparison of steroid-eluting transvenous (n=13) leads at 1.0 ms pulse width (0.58±0.39 V) vs. conventional transvenous leads (n=9) (0.43±0.17 V) revealed no significant difference. Sensing for ventricular epicardial leads (n=10) was 12.7±5.1 vs. 9.0±3.3 mV (n=11) transvenous (ns). Impedance for epicardial leads (n=13) was 415±161 vs. 560±152 (n=12) (transvenous) (P<0.05).

View larger version (24K): [in this window] [in a new window]   Fig. 1. Acute ventricular stimulation threshold. Acute stimulation threshold of steroid-eluting epicardial leads is indicated by *.

3.5. Date of operation
To detect whether the dates of operation were comparable between patients with epicardial and transvenous pacing the total observation interval was divided into two groups: From 1979 to 1989 12 patients underwent epicardial and two patients transvenous lead placement. From 1990 to1998 37 patients underwent epicardial and 20 patients transvenous lead placement. The Fisher exact test did not reveal a significant difference.

3.6. Reoperations
During follow-up 23/71 (32%) patients underwent 40 pace device-related reoperations; 23 patients required a second operation, ten of these patients a third, and two required four to seven operations (Table 3). Patients with epicardial lead placement underwent 31 pace device-related reoperations, patients after transvenous lead implantation required seven reoperations. Age-adjusted Cox regression revealed no significant different reoperation rate among both groups. Battery depletion (n=12) occurred after 3.4±2.5 years (74 days–9.2 years). In 9/12 (75%) battery durability was less than four years. Increase in ventricular stimulation threshold resulting in a reoperation occurred in eight patients after 1.5±1.8 years (2 days–4.5 years). In 6/8 (75%) of cases reoperation was necessary in less than 1.5 years after implantation. The age-adjusted rate of lead-related reoperation was significantly lower for patients with epicardial lead placement (P<0.05). Lead-related was defined as reoperation due to early battery depletion (<4 years), chronic stimulation threshold increase, lead fracture, lead dislocation, sensing dysfunction, and exit block (Fig. 2).

View larger version (9K): [in this window] [in a new window]   Fig. 2. Lead-related reoperation-free interval of pediatric patients with transvenous or epicardial stimulation.

A special procedure was performed in two patients in whom a rapid increase of the epicardial chronic ventricular stimulation threshold occurred. One patient had undergone tricuspid valve replacement and the second patient had undergone a Fontan-type procedure. Therefore, epicardial ventricular pacing was mandatory. In both patients two ventricular steroid-eluting electrodes were connected to a DDD mode pacemaker to have double options in case of a malfunction of one lead. Since implantation (9 and 15 months) these leads show good ventricular stimulation thresholds, lead impedance, and sensing.

3.7. Mortality
Two out of eight postoperative deaths (25%) were probably related to the pacing system. A 3.4-year-old boy, operated on for tricuspid atresia, died because of ventricular fibrillation one day after epicardial VVI (Siemens Dialog II, Medtronic 4951/35) implantation. Already intraoperatively, ventricular fibrillation occurred, but check of the pacesystem did not reveal any abnormalities. Retrospectively, a sensing defect is most likely the cause of death.

A 2.4-year-old girl, operated on for L-TGA with VSD died 41 days after epicardial VVI implantation (Medtronic Minix, Medtronic 4951/35). The clinical condition of the patient was good, so a pacesystem dysfunction has to be assumed.

In the remaining six patients the underlying cardiac disease and the clinical course explained the cause of death. In all of these six patients pacemaker check-up was normal. Two of these patients had undergone transvenous lead placement.

	4. Discussion

Top Abstract 1. Introduction 2. Materials and methods 3. Results 4. Discussion Appendix A. Conference... References

 
Damage to the conduction system after open-heart surgery for congenital heart disease with an incidence of about one percent was found to be the main cause for permanent cardiac pacing in our patients. These results are in line with observation of other studies [1–3].

Epicardial pacing is usually established because of either cardiac anatomy or small body size [1,7,8] which is confirmed by our experience. If the anatomical route for transvenous ventricular pacing is impossible as e.g. in patients after Fontan-type procedures or tricuspid valve replacement epicardial ventricular pacing is necessary. In contrast, if a congenital complete heart block is present in a newborn there is usually little alternative to epicardial pacing.

In the early 1980s four critera for transvenous pacing were postulated: age of four years or more, weight of 15 kg or more, no right to left shunt, adequate superior vena caval to right atrial communication, and no simultaneous cardiac operation [8]. An adequate size of the cephalic or subclavian vein allowing the passage of the lead is important, although we inserted transvenous leads via the internal jugular vein in two patients. Furthermore, we were concerned about the development of venous thrombosis due to a disproportion between vessel and lead in small patients. In general, this complication occurs approximately in 30–45% of patients after transvenous pacemaker implantation. Chronic thrombosis mostly remains asymptomatic due to collateral circulation, whereas acute thrombosis usually is symptomatic, requiring anticoagulation, thrombolytic therapy, surgical intervention, and percutaneous transluminal balloon venoplasty [9]. In our series no signs of acute vein thrombosis occurred. However, chronic thrombosis is usually asymptomatic and ultrasound investigations were not performed, therefore, the number of patients with thrombosis remains unclear. Because of these considerations the purely ventricular pacing mode was mainly used in transvenous pacing in our series. However, it has been shown that, because of developement of smaller pacemaker generators and transvenous leads transvenous ventricular pacing (VVI) can be established in newborns of 2.8 kg body weight and atrioventricular synchronized pacing (DDD) in children at the age of 3 years and 12.8 kg body weight [10] without considerable pacing device-related mortality and morbidity. Neither in this study nor in other studies lead-related vein thrombosis was observed [10,11]. Growth-related problems such as lead dislocation or fracture can be expected, but on the other hand can be prevented by creating an atrial loop of the venticular lead. Growth related problems were not seen in our or other large series [8,12].

Apart from these anatomical considerations epicardial and transvenous devices have striking different acute and chronic pacing characteristics. Epicardial leads have a higher acute stimulation threshold which does usually not decreases significantly by time [1,3]. It rather proceeds resulting in a high chronic ventricular stimulation threshold causing higher energy consumption resulting in an earlier battery depletion [1,3,6,7,13,14]. Consecutively, we found a higher rate of lead related reoperations due to chronic threshold rise and early battery depletion in the group of epicardial pacing. However, the patients in the epicardial group were significantly younger demanding a higher pacing rate – and in this group the number of patients with operated congenital heart disease is higher assuming an epicardial surface with variable degrees of fibrosis from scar tissue formation or pericardial adhesions causing higher stimulation thresholds. These two factors may contribute to early battery depletion, too.

High pacing rates, the ample stimulation safety margin, and cardiovascular anatomy precluding endocardial lead placement lead to increased energy consumption in pediatric patients. For this patient population the implantation of an autocapsure devices in combination with steroid-eluting epicardial leads have resulted in substantial energy savings and markedly extended battery life [15].

Early experience with the Medtronic 4951 fishhook lead in 1984, our predominantly implanted epicardial lead, revealed good chronic stimulation thresholds [16], but these results were not confirmed by our data or other studies [17]. The own experience with steroid-eluting leads as first line epicardial electrodes in a few patients and in patients with mandatory epicardial pacing and refractory stimulation threshold increase is promising. Furthermore, it has been shown that steroid-eluting epicardial leads have the same longevity as the conventional transvenous leads [7] maintaining stable low thresholds irrespective of pacing site and associated cardiac surgery [18]. Another approach in these patients could be a transatrial or transventricular insertion of endocardial leads [19], or the transvenous implantation via the coronary sinus in patients e.g. after a Fontan-type operation [20]. In addition to stimulation threshold increase and battery depletion, lead fractures were more often in patients with epicardial leads. This complication is clearly associated with this type of leads [1,3].

The majority of postoperative death were because of the underlying cardiac disease, but one has to be aware of potentially life-threatening complications suspected in two patients. In other series potentially pacemaker-related death is about 2% [1,3].

Permanent pediatric pacing remains a rare therpeutical procedure mainly necessary after surgery for intracardiac malformations. Transvenous pacing is associated with a lower rate of lead-related reoperations. Patient size, cardiac defects, and vascular and valvular concerns may limit transvenous lead utilization. Reports on steroid-eluting epicardial leads, paticularly in combination with autocapture controlled devices, and our little experience underline the value of these advances.

	Footnotes

 
Presented at the 13th Annual Meeting of the European Association for Cardio-thoracic Surgery, Glasgow, Scotland, UK, September 5–8, 1999.

	Appendix A. Conference discussion

Top Abstract 1. Introduction 2. Materials and methods 3. Results 4. Discussion Appendix A. Conference... References

 
Dr J. Melo (Carnaxide, Portugal): If you have a problem and have to remove a lead, what is your approach? For babies and children, they grow and you have to replace the leads. How do you deal with that problem with your endocardial approach?

Dr Sachweh: If you have a patient which is VVI paced and the lead is placed on the diaphragmatic part of the ventricle, maybe it is possible to remove the lead by a subxiphoidal approach. Otherwise you have to perform a resternotomy, for example, to remove this lead. So it always represents major surgery.

Dr Melo: And for the endocardial leads, if you have to remove the endocardial leads?

Dr Sachweh: Yes, if we have to remove endocardial leads, we usually try to pull them very carefully, and usually it works.

Dr Melo: Do you have any experience with laser-extracting sheats inserted outside the endocardial leads to remove it completely?

Dr Sachweh: No, we don't have any experience with that.

	References

Top Abstract 1. Introduction 2. Materials and methods 3. Results 4. Discussion Appendix A. Conference... References

 

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2. Bonatti V., Agnetti A., Squarcia U. Early and late postoperative complete heart block in pediatric patients submitted to open heart surgery for congenital heart disease. Pediatr Med Chir 1998;20(3):181-186.[Medline]
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4. Henglein D., Gillette P.C., Shannon C., Burns G. Long-term follow-up of pulse width threshold of transvenous and myo-epicardial leads. Pace 1984;7:203-214.
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8. Gilette P.C., Shannon C., Blair H. Transvenous pacing in paediatric patients. Am Heart J 1983;105:843-847.[Medline]
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11. Gilette P.C., Zeigler V., Bradham G.B. Pediatric transvenous pacing: A concern for venous thrombosis?. Pace 1988;11:1935-1939.
12. Ward D.E., Jones S., Camm A.J. Long-term endocardial pacing in congenital heart disease. Clin Prog Electrophysiol Pacing 1985;3:133-144.
13. Weber H., Schmitz L., Eigster G., Hellberg K., de Vivie E.R. Permanent pacing in the pediatric age group: indications and long-term results. Pace 1983;6:95.
14. Ward D.E. Permanent pacing in children. In: Anderson R.H., Mccartney F.J., Shinebourne E.A., Tynan M., eds. Pediatric cardiology. Edinburgh: Churchill Livingstone, 1983:34-46.
15. Bauersfeld U., Nowak B., Molinari L., Malm T., Kampmann C., Schonbeck M.H., Schuller H. Low-energy epicardial pacing in children: the benefit of autocapsure. Ann Thorac Surg 1999;68(4):1380-1383.[Abstract/Free Full Text]
16. Michalik R.E., Williams W.H., Zorn-Chelton S., Hatcher C.R. Experience with a new pacing lead in children. Pace 1984;7:831-838.
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